Centers for Disease Control and Prevention

National Center for Immunization and Respiratory Diseases

Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation 

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Evidence to Recommendations Framework:

2023 – 2024 (Monovalent, XBB Containing) COVID-19 Vaccine

Megan Wallace, DrPH, MPH

ACIP Meeting 

September 12, 2023
Evidence to Recommendations Framework 
▪ Structure to describe information considered in moving from evidence to ACIP vaccine 

recommendations

▪ Provide transparency around the impact of additional factors on deliberations when 

considering a recommendation 

Evidence to Recommendations (EtR) Framework 

3
4 4

Evidence to Recommendations (EtR) Framework 

EtR Domain Question(s)

Public Health Problem • Is the problem of public health importance?

Benefits and Harms

• How substantial are the desirable anticipated effects?

• How substantial are the undesirable anticipated effects?

• Do the desirable effects outweigh the undesirable effects?

Values

• Does the target population feel the desirable effects are large relative to 

the undesirable effects?

• Is there important variability in how patients value the outcome?

Acceptability • Is the intervention acceptable to key stakeholders?

Feasibility • Is the intervention feasible to implement?

Resource Use • Is the intervention a reasonable and efficient allocation of resources?

Equity • What would be the impact of the intervention on health equity?
5 5

Evidence to Recommendations (EtR) Framework 

EtR Domain Question(s) Domain Equity Question(s)

Public Health 

Problem • Is the problem of public health importance? • Does the problem impact all populations equally?

Benefits and 

Harms

• How substantial are the desirable anticipated effects?

• How substantial are the undesirable anticipated effects?

• Do the desirable effects outweigh the undesirable 

effects?

• Are the desirable and undesirable anticipated effects 

demonstrated across all populations equally?

Values

• Does the target population feel the desirable effects are 

large relative to the undesirable effects?

• Is there important variability in how patients value the 

outcome?

• Is there important variability in how patients or 

populations value the outcome?

Acceptability • Is the intervention acceptable to key stakeholders? • Is the intervention equally acceptable across all 

populations?

Feasibility • Is the intervention feasible to implement? • Is the intervention equally feasible to implement across 

all populations?

Resource Use • Is the intervention a reasonable and efficient allocation 

of resources?

• Is the intervention a reasonable and efficient allocation 

of resources across all populations?

The intervention = 2023 – 2024 (monovalent, XBB containing) COVID-19 vaccine 

The problem = COVID-19 
▪ Should 2023 - 2024 (monovalent, XBB containing) COVID-19 vaccines authorized under 

EUA or approved by BLA be recommended for use in persons ≥6 months of age?

Products and ages currently authorized or approved by FDA include:

▪ Moderna COVID-19 vaccine for ages 6 months and older

▪ Pfizer-BioNTech COVID-19 vaccine for ages 6 months and older

Products and ages under review for authorization or approval by FDA include:

▪ Novavax COVID-19 vaccine for ages 12 years and older

Evidence to Recommendations (EtR) Framework

Policy Question

EUA: Emergency Use Authorization; BLA: Biologics License Application 6
7

Bivalent COVID-19 vaccine recommendations for mRNA 

COVID-19 vaccines

≥5/6 years 6 months – 4/5 years

2 doses 

Moderna

3 doses 

PfizerBioNTech

OR

1 dose 

Moderna

1 dose 

PfizerBioNTech

Unvaccinated OR

Previously 

vaccinated

≥6 months

1 dose 

Moderna

1 dose 

PfizerBioNTech

OR

Note: Those ages 6 months – 4 years who have previously received a single dose of Pfizer-BioNTech would need 2 additional doses. Additional doses are recommended for persons with 

immunocompromising conditions.
8

Proposed 2023 – 2024 COVID-19 vaccine recommendations 

for mRNA COVID-19 vaccines

6 months – 4 years ≥ 5 years

2 doses 

Moderna

3 doses 

PfizerBioNTech

OR

1 dose 

Moderna

1 dose 

PfizerBioNTech

Unvaccinated OR

Previously 

vaccinated

≥6 months

1 dose 

Moderna

1 dose 

PfizerBioNTech

OR

Note: Those ages 6 months – 4 years who have previously received a single dose of Pfizer-BioNTech would need 2 additional doses. Additional doses are recommended for persons with 

immunocompromising conditions.
▪ The original Novavax COVID-19 vaccine remains authorized for use as a 2-dose primary 

series 

▪ The original Novavax COVID-19 vaccine can be given as booster dose in limited 

situations to 

– People ages 18 years and older who previously completed primary vaccination using 

any FDA-approved or FDA-authorized COVID-19 vaccine

– Have not received any previous booster dose(s) 

– Are unable (i.e., mRNA vaccine contraindicated or vaccine not available) or unwilling 

to receive an mRNA vaccine and would otherwise not receive a booster dose

▪ Authorizations or approvals for 2023 – 2024 Novavax COVID-19 vaccine will be 

determined by FDA with CDC recommendations to follow

Current recommendations for Novavax COVID-19 vaccine

9
▪ Updated COVID-19 vaccine referred to as the “2023–2024 COVID-19 vaccine” in this 

presentation

▪ Following ACIP meeting, both “updated COVID-19 vaccine” and “2023–2024 COVID-19 

vaccine” will be used to refer to the monovalent XBB.1.5 containing vaccines

COVID-19 vaccine nomenclature 

10
EtR Domain:

Public Health Problem 
Weekly Population-Based Rates of COVID-19-Associated 

Hospitalizations — COVID-NET, March 2020–August 26, 

2023

0

20

40

60

80

100

120

140

3/7/2020

5/7/2020

7/7/2020

9/7/2020

11/7/2020

1/7/2021

3/7/2021

5/7/2021

7/7/2021

9/7/2021

11/7/2021

1/7/2022

3/7/2022

5/7/2022

7/7/2022

9/7/2022

11/7/2022

1/7/2023

3/7/2023

5/7/2023

7/7/2023

Rate per 100,000 population

Week Ending Date

March 1, 2020–August 26, 2023

<6 months 6 months–4 years 5–11 years 12–17 years

18–49 years 50–64 years 65–74 years ≥75 years

0

20

40

60

80

100

120

140

Rate per 100,000 population

Week Ending Date

January 1–August 26, 2023

Gray boxes indicate potential reporting delays. Interpretation of trends should be excluded from these weeks. 

Rates highest in ≥75 years, followed by 

infants <6 months and adults 65–74 years

12
13

COVID-19 new hospital admissions, by week, in the United States 

National Healthcare Safety Network (NHSN), August 2020 – August 2023

Source: COVID-19–associated hospitalization data reported to CDC’s National Healthcare Safety Network (NHSN). 

https://covid.cdc.gov/covid-data-tracker/#trends_weeklyhospitaladmissions_select_00
14 14

Other pediatric vaccine preventable diseases: Annual hospitalizations per 

100,000 population prior to recommended vaccines compared to COVID-19 

1 https://www.cdc.gov/mmwr/preview/mmwrhtml/ss5603a1.htm

2Davis MM, Patel MS, Gebremariam A. Decline in varicella-related hospitalizations and expenditures for children and adults after introduction of varicella vaccine in the United 

States. Pediatrics. 2004;114(3):786-792. doi:10.1542/peds.2004-0012

3 Centers for Disease Control and Prevention (CDC). Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of 

invasive pneumococcal disease--United States, 1998-2003. MMWR Morb Mortal Wkly Rep. 2005 Sep 16;54(36):893-7. PMID: 16163262.

4 COVID-NET data October 2021 – September 2022 and October 2022 – July 2023. COVID-19 rates have not been adjusted for reason for admission. COVID vaccine first introduced 

in 12-17 years in May 2021; in 5-11 years in November 2021 and in 6 months – 4 years in June 2022

Hepatitis A1

Varicella2

(Chickenpox)

Vaccine-type 

Invasive 

Pneumococcal 

Disease3

COVID-194

Age 5–14 years 0–4 years 0–4 years 6 months–<18 years

Time period 2005 1993–1995 1998–1999 2021–2022

2022–2023

Hospitalization 

Burden

(Annual rate per 

100,000 population)

<1 29-42 405

≤4 years: 92–220

5–11 years: 15–47

12–17 years: 20–80
15 15

COVID-19 Scenario Modeling Hub

https://covid19scenariomodelinghub.org/

▪ A multi-team effort aimed at creating and modeling planning scenarios of the mid- to 

long-term COVID-19 situation

▪ Scenarios developed in close collaboration with government agencies and other 

stakeholders 

▪ Project hospitalizations and deaths
16 16

Assumptions of COVID-19 Scenario Modeling Hub Round 17

1. Low immune escape: immune escape occurs at a constant rate of 20% per year; high immune escape: immune escape occurs at a constant rate of 50% per year

▪ Six scenarios focusing on three vaccine recommendation scenarios and two different 

rates of immune escape

– No vaccine recommendation vs recommendation for 65+ years vs universal 

recommendation

– Low immune escape vs high immune escape1

▪ Assumed vaccines reformulated to target strains circulating on June 15th of each year, 

made available September 1

▪ Reformulated vaccines assumed to have 65% VE against symptomatic infection with the 

strain targeted by reformulation

▪ Vaccine uptake based on first booster uptake (September 2021) 

▪ Teams required to project a minimum of 2 years into the future

▪ Eight teams provided national level projections
17 17

Based on ensemble projections, weekly hospitalizations are likely to 

increase this winter and stay within last year’s range

https://covid19scenariomodelinghub.org/
18 18

People ages 6 months – 49 years with no underlying conditions are still 

admitted to the ICU with COVID-19

COVID-NET: Underlying Medical Conditions among Patients Admitted to ICU among Children, Adolescents, 

and Adults Ages 6 Months – 49 Years, July 2022–June 2023

• Relative standard errors >30%; estimates might be unstable due to small sample size

• Limited to COVID-NET hospitalizations with COVID-19-related illness as likely reason for admission

Age category

% with no 

underlying 

conditions

Of those with no 

underlying 

conditions, what % 

were admitted to 

ICU?

6–23 months 57% 27%

2–4 years 39% 19%

5–11 years 24% 23%

12–17 years 25% 31%

18–49 years 16% 15%

% admitted to ICU 

with no 

underlying 

conditions

53%

32%

24%

22%

13%
19

Provisional COVID-19 deaths, by week, in the United States, 

reported to CDC

The most recent 3 weeks of mortality counts are shaded grey because NVSS reporting is <95% during this period.

Source: Provisional Deaths from the CDC’s National Center for Health Statistics (NCHS) National Vital Statistics System (NVSS). https://covid.cdc.gov/covid-datatracker/#trends_weeklydeaths_weeklydeathrateaa_00
20

COVID-19-associated deaths in persons ages ≥20 years (by underlying 

cause of death), by age group and year – National Vital Statistics System

1 Provisional data

2 Partial data

Source: Centers for Disease Control and Prevention, National Center for Health Statistics. National Vital Statistics System, Provisional Mortality on CDC WONDER Online Database. 

Data are from the final Multiple Cause of Death Files, 2018-2021, and from provisional data for years 2022-2023, as compiled from data provided by the 57 vital statistics 

jurisdictions through the Vital Statistics Cooperative Program. Number of deaths includes COVID-19 code (U07.1) as the underlying cause of death. Accessed at 

http://wonder.cdc.gov/mcd-icd10-provisional.html on Aug 25, 2023 4:53:59 PM

8716

59,054

282,836

23,189

110,606

282,457

5764

33,895

146,255

451 2821

24,776

0

50000

100000

150000

200000

250000

300000

20-44 years 45-64 years 65+ years 20-44 years 45-64 years 65+ years 20-44 years 45-64 years 65+ years 20-44 years 45-64 years 65+ years

2020 2021 2022 Jan 1 - July 22, 2023

Number of Deaths

1
21

COVID-19-associated deaths in persons ages ≤19 years (by underlying 

cause of death), by age group and year – National Vital Statistics System

1 Provisional data

2 Partial data

Source: Centers for Disease Control and Prevention, National Center for Health Statistics. National Vital Statistics System, Provisional Mortality on CDC WONDER Online Database. 

Data are from the final Multiple Cause of Death Files, 2018-2021, and from provisional data for years 2022-2023, as compiled from data provided by the 57 vital statistics 

jurisdictions through the Vital Statistics Cooperative Program. Number of deaths includes influenza codes (J09-J11) or COVID-19 code (U07.1) as the underlying cause of death. 

Accessed at http://wonder.cdc.gov/mcd-icd10-provisional.html on Aug 25, 2023 4:53:59 PM

35 19

167

91

54

493

156

101

292

26 18

36

0

100

200

300

400

500

600

<1 year 1-4 years 5-19 years <1 year 1-4 years 5-19 years <1 year 1-4 years 5-19 years <1 year 1-4 years 5-19 years

2020 2021 2022 Jan 1 - July 22, 2023

Number of Deaths

1
22

Among children ≤17 years who died in-hospital, 50% had no underlying 

conditions

COVID-NET: Underlying Medical Conditions among Patients with In-Hospital Death among 

Children and Adolescents Ages ≤17 Years, January 2022–June 2023

Limited to COVID-NET hospitalizations with COVID-19-related illness as likely reason for admission

* Relative standard error >30; indicates estimate might be unstable due to low sample size (n=24).

Age category

% with no 

underlying 

conditions

Of those with no 

underlying 

conditions, what % 

died in-hospital?

≤17 years 51% 1%*

% of those who died 

in-hospital with no 

underlying 

conditions

50%
23

1Vogt TM , Wise ME, Bell BP, Finelli L. Declining hepatitis A mortality in the United States during the era of hepatitis A vaccination. J Infect Dis2008; 197:1282–8.

2National Notifiable Diseases Surveillance System with additional serogroup and outcome data from Enhanced Meningococcal Disease Surveillance for 2015-2019.

3Meyer PA, Seward JF, Jumaan AO, Wharton M. Varicella mortality: trends before vaccine licensure in the United States, 1970-1994. J Infect Dis. 2000;182(2):383-390. 

doi:10.1086/315714

4Roush SW , Murphy TV; Historical comparisons of morbidity and mortality for vaccine-preventable diseases in the United States. JAMA 2007; 298:2155–63.

5 Glass RI, Kilgore PE, Holman RC, et al. The epidemiology of rotavirus diarrhea in the United States: surveillance and estimates of disease burden. J Infect Dis. 1996 Sep;174 Suppl 1:S5-11

6 http://wonder.cdc.gov/mcd-icd10-provisional.html on Aug 1, 2023 . COVID vaccine first introduced in 12-17 years in May 2021; in 5-11 years in November 2021 and in 6 months – 4 

years in June 2022

Pediatric vaccine preventable diseases: Deaths per year in the United 

States prior to recommended vaccines compared to COVID-19

Hepatitis A1 Meningococcal 

(ACWY)2

Varicella3 Rubella4 Rotavirus5 COVID-196

Age <20 years 11–18 years 5–9 years All ages <5 years 6 months–<18 years

Time 

period 1990–1995 2000–2004 1990–1994 1966–1968 1985–1991 2022

Average 

deaths 

per year

3 8 16 17 20

≤1 year: 156

1–4 years: 101

5–19 years:292
24

COVID-19 and Influenza -associated deaths in persons ages ≤19 years (by 

underlying cause of death), by age group and year – National Vital Statistics 

System

1 Provisional data

2 Partial data

Source: Centers for Disease Control and Prevention, National Center for Health Statistics. National Vital Statistics System, Provisional Mortality on CDC WONDER Online Database. 

Data are from the final Multiple Cause of Death Files, 2018-2021, and from provisional data for years 2022-2023, as compiled from data provided by the 57 vital statistics 

jurisdictions through the Vital Statistics Cooperative Program. Number of deaths includes influenza codes (J09-J11) or COVID-19 code (U07.1) as the underlying cause of death. 

Accessed at http://wonder.cdc.gov/mcd-icd10-provisional.html on Aug 25, 2023 4:53:59 PM

35 19

167

91

54

493

156

101

292

26 18 36

14

48

96

0 0 0

12

54

103

0

18 10

0

100

200

300

400

500

600

<1 year 1-4 years 5-19 years <1 year 1-4 years 5-19 years <1 year 1-4 years 5-19 years <1 year 1-4 years 5-19 years

2020 2021 2022 Jan 1 - July 22, 2023

Number of Deaths

COVID Influenza

1
Domain Equity Question:

Does the problem impact all populations equally?
26 26

Age-adjusted COVID-19-associated hospitalization rates by 

race and ethnicity* — COVID-NET, October 2022 –August 

2023

* Black, White, American Indian/Alaska Native and Asian/Pacific Islander people were categorized as non-Hispanic; Hispanic people 

could be of any race. 

Cumulative hospitalization rates remain highest in 

American Indian/Alaska Native and Black persons

Source: COVID-NET: https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html. Data March 1, 2020 through August 26, 2023. 

0

2

4

6

8

10

12

14

16

1/7/2023 2/7/2023 3/7/2023 4/7/2023 5/7/2023 6/7/2023 7/7/2023 8/7/2023

Rates per 100,000 population

3-week moving average rate 

January – August 2023

White Black Asian/Pacific Islander American Indian/Alaskan Native Hispanic

0

50

100

150

200

250

300

350

Rates per 100,000 

Cumulative rates 

October 2022 – August 2023
27 27

Risk ratio of death, invasive mechanical ventilation (IMV), and admission to intensive 

care unit (ICU), by the number of underlying medical conditions among adults 

hospitalized with COVID-19, March 2020–March 2021

Kompaniyets L, Pennington AF, Goodman AB, Rosenblum HG, Belay B, Ko JY, et al. Underlying Medical Conditions and Severe Illness Among 540,667 Adults Hospitalized With COVID19, March 2020–March 2021. Prev Chronic Dis 2021;18:210123. DOI: http://dx.doi.org/10.5888/pcd18.210123
28 28

Prevalence of any 

condition:

Selected chronic conditions by U.S. county, 2018

Based on Razzaghi H, Wang Y, Lu H, Marshall KE, Dowling NF, Paz-Bailey G,Twentyman ER, Peacock G, Greenlund KJ, Estimated County-Level Prevalence of Selected Underlying Medical Conditions 

Associated with Increased Risk for Severe COVID-19 Illness - United States, 2018 MMWR Morb Mortal Wkly Rep 2020;69[945-950]. The underlying medical conditions included in these prevalence 

estimates were selected using a subset of the list of conditions with the strongest and most consistent evidence of association with increased risk for severe COVID-19-associated illness on CDC’s website 

as of June 25, 2020 and for which questions on the BRFSS are available. https://covid.cdc.gov/covid-data-tracker/#underlying-med-conditions

(%)
29 29

Number of chronic conditions by age among Asian, Black, Latino/Hispanic, 

and White adults in the National Health Interview Survey, 1999 to 2018

Source: Caraballo C, Herrin J, 

Mahajan S, et al. Temporal Trends in 

Racial and Ethnic Disparities in 

Multimorbidity Prevalence in the 

United States, 1999-2018. Am J Med. 

2022;135(9):1083-1092.e14. 

doi:10.1016/j.amjmed.2022.04.010 
▪ COVID-19 burden is currently lower than at previous points in the pandemic, however the 

absolute number of hospitalizations and deaths is still high

▪ Although hospitalization rates are currently low in some age groups, we have seen rates 

increase in recent weeks and anticipate further increases as we enter respiratory virus season

▪ Infants and older adults have the highest COVID-19-associated hospitalization rates

▪ Children and adults with no underlying medical conditions still experience severe illness due to 

COVID-19

▪ Post-COVID Conditions are common following SARS-CoV-2 infection, decrease with time since 

infection, and have decreased since the start of the pandemic

▪ People of racial and ethnic minority groups continue to be disproportionately impacted by 

COVID-19

▪ High proportions of underlying conditions may put certain groups at increased risk for severe 

outcomes due to COVID-19

Summary 

Public Health Problem 

30
Public Health Problem

Work Group Interpretation

Is COVID-19 disease among persons ≥ 6 months of public health importance?

oNo oProbably no oProbably yes oYes oVaries oDon’t know
EtR Domain:

Benefits and Harms 
▪ Data from COVID-19 vaccine manufacturers 

– Moderna monovalent XBB.1.5 containing vaccine clinical trial data

– Novavax monovalent XBB.1.5 containing preclinical data

– Pfizer-BioNTech monovalent XBB.1.5 containing preclinical data

▪ GRADE

– Benefits and harms of an updated COVID-19 vaccine

▪ Post-authorization safety and effectiveness monitoring

– Vaccine Safety Datalink and other vaccine safety monitoring systems

– CDC vaccine effectiveness platforms

▪ Additional considerations

– Benefit-risk assessment

– Modeling data

Summary of available data

33
▪ Moderna

– Clinical trial data

• Randomized 101 patients to monovalent XBB.1.5 containing dose or bivalent BA.4/5 + XBB.1.5 containing dose

• Patients that received the monovalent XBB.1.5 containing dose demonstrated an increase in neutralizing 

antibodies, with similar levels of neutralization across several XBB sub-variants

• Reported reactogenicity was similar to or lower than that reported from previous doses

▪ Novavax

– Preclinical data

• Macaques boosted with XBB.1.5 demonstrated increased neutralizing response across several XBB 

pseudoviruses

▪ Pfizer-BioNTech

– Preclinical data

• Mice boosted with XBB.1.5 demonstrated increased neutralizing response across several XBB pseudoviruses

Available data from COVID-19 vaccine manufacturers 

34
▪ GRADE approach was applied to assess the type and quality of evidence for the 

anticipated benefits and harms of an updated COVID-19 vaccine

▪ The PICO question and inclusion/exclusion criteria were intentionally narrow to best 

capture evidence most applicable to what can be anticipated from this year’s vaccine 

dose in the U.S., including limiting evidence to U.S. studies of an updated vaccine 

formulation (i.e., bivalent mRNA vaccine)

▪ Two separate PICO questions were evaluated based on dosing cut-offs 

▪ These narrow criteria reduced the number of studies available in the body of evidence, 

however this GRADE assessment builds upon a large body of evidence from the original 

monovalent vaccines

GRADE 

BLA: Biologics License Application; EUA: Emergency Use Authorization 35
36 36

PICO Question – Adolescents and Adults

Population Persons ages 12 years and older

Intervention Updated mRNA COVID-19 vaccine

Comparison No updated vaccine

Outcomes Medically-attended COVID-19 (ED/UC visits)

Hospitalization due to COVID-19

Death due to COVID-19

Post-COVID Conditions 

Specified Serious Adverse Events

Reactogenicity

PICO: Population, intervention, comparison, outcomes ED: emergency department; UC: urgent care
37 37

PICO Question - Infants and Children

Population Persons ages 6 months – 11 years

Intervention Updated COVID-19 mRNA vaccine

Comparison No updated vaccine

Outcomes Medically-attended COVID-19 (ED/UC visits) 

Hospitalization due to COVID-19

Death due to COVID-19

MIS-C

Post-COVID Conditions

Specified Serious Adverse Events

Reactogenicity

PICO: Population, intervention, comparison, outcomes ED: emergency department; UC: urgent care MIS-C: Multisystem inflammatory syndrome in children 
38 38

Outcomes, Importance, and Data Sources 

a Three options: Critical; Important but not critical; Not important for decision making

OutcomeImportancea Data sources

Benefits

Medically-attended COVID19 (ED/UC visits) Critical Observational studies of vaccine effectiveness 

Hospitalization due to COVID-19Critical Observational studies of vaccine effectiveness 

Death due to COVID-19 Important Observational studies of vaccine effectiveness 

MIS-C – pediatrics only Important Observational studies of vaccine effectiveness 

Post-COVID Conditions Important Observational studies of vaccine effectiveness 

Harms

Specified serious adverse events 

(SAEs) Critical Safety surveillance for specified SAEs 

Reactogenicity Important RCTs for monovalent doses

ED: emergency department; UC: urgent care MIS-C: Multisystem inflammatory syndrome in children 
Evidence Retrieval

▪ Observational Studies for Benefits (Vaccine Effectiveness)

– Published or preprint articles from International Vaccine Access Center (IVAC) 

systematic reviewa

– Restricted to PICO defined population, intervention, comparison, and outcome

▪ Safety Surveillance for Serious Adverse Events

– Data on safety signals identified by vaccine safety surveillance systems

– Based on input from CDC Immunization Safety Office (ISO)

▪ Randomized Controlled Trials (RCTs) for Reactogenicity

– Data on reactogenicity identified by relevant phase 1, 2, or 3 RCTs from 

clinicaltrails.gov

– Unpublished data from vaccine manufacturers

39 a Articles were eligible for inclusion if published or uploaded to a preprint server before 6/29/2023;
Observational Data (n = 6)

▪ 6 records identified (one or more PICO outcomes)

▪ Assessed risk of bias using Newcastle-Ottawa Scale (9-point scale)

– For cohort studies: Selection of cohorts, Comparability of cohorts, Assessment of 

outcome

– For case-control or test-negative design studies: Selection of cases and controls, 

Comparability of cases and controls, Ascertainment of exposure

▪ Two reviewers assessed each study for each outcome

▪ Serious limitations identified by score <7

40
Pooling of Vaccine Effectiveness (VE) Estimates

▪ For each outcome, assessed body of evidence for suitability for pooling

– Most representative study selected if multiple studies in same population

▪ Meta-analyses conducted 

▪ Estimates evaluated for heterogeneity

▪ Resulting pooled estimates summarize real-world data available at time of GRADE 

analysis

41
42 42

Pooled VE = 53.1% (95% CI: 49.7% to 56.3%)*

0 10 20 30 40 50 60 70 80 90 100

Vaccine Effectiveness

Tenforde, ≥7 days post bivalent dose, ≥2 monovalent doses comparator

Tseng, ≥14 days post bivalent dose, ≥2 monovalent doses comparator

Pooled Estimate

Medically-Attended COVID-19 (ED/UC Visits), 

Adults and Adolescents (n=2)

*Pooled RR based on a fixed effects meta-analysis, using adjusted vaccine effectiveness estimates on a log scale. Fixed effects model was used for this 

analysis due to imprecise estimates of the between-studies variance.

ED: emergency department; UC: urgent care
GRADE: Medically-Attended COVID-19 (ED/UC Visits), Adults 

and Adolescents (n=2)

▪ Observational Studies (n=2)

▪ Pooled RR 0.47 (95% CI: 0.44 to 0.50)

▪ No serious concerns in certainty assessment. 

▪ Evidence type: Low certainty 

43

CI: Confidence interval; RR: Risk ratio; ED: emergency department; UC: urgent care
44 44

Pooled VE = 47.8% (95% CI: 29.6% to 61.4%)*

*Pooled RR based on a random effects meta-analysis, using adjusted vaccine effectiveness estimates on a log scale.

Note: 6 studies were identified in the systematic review, however 2 studies had overlapping populations and were excluded from the pooled 

analysis.

-40 -20 0 20 40 60 80 100

Vaccine Effectiveness

Tseng , ≥ 14 post bivalent dose, ≥2 monovalent doses comparator

Lin, ≥ 14 days post bivalent dose, ≥2 monovalent doses comparator

Link-Gelles, unvaccinated comparator 

Surie, ≥2 monovalent doses comparator

Link-Gelles, unvaccinated comparator

Surie, ≥2 monovalent doses comparator 

Link-Gelles, unvaccinated comparator

Surie, ≥2 monovalent doses comparator

Pooled Estimate

7-59 days post 

bivalent dose 

60-119 days post 

bivalent dose 

120-179 days post 

bivalent dose 

Hospitalization due to COVID-19, Adults and Adolescents (n=4)
GRADE: Hospitalization due to COVID-19, Adults and Adolescents 

(n=4) 

▪ Observational Studies (n=4)

▪ Pooled RR 0.52 (95% CI: 0.39–0.70)

▪ No serious concerns in certainty assessment.

▪ Evidence type: Low certainty

45

CI: Confidence interval; RR: Risk ratio
46 46

Death due to COVID-19, Adults and Adolescents (n=2)

0

1

2

3

4

0 10 20 30 40 50 60 70 80 90 100

Vaccine Effectiveness

Lin, ≥14 days post bivalent dose, ≥2 monovalent doses comparator

Tseng, ≥14 days post bivalent dose, ≥2 monovalent doses comparator

Pooled Estimate

Pooled VE = 60.5% (95%CI: 40.7% to 73.7%)*

*Pooled RR based on a fixed effects meta-analysis, using adjusted vaccine effectiveness estimates on a log scale. Fixed effects model was used for this 

analysis due to imprecise estimates of the between-studies variance.
47

▪ Observational Studies (n=2)

▪ Pooled RR 0.39 (95% CI: 0.26 to 0.59)

▪ Serious concern for inconsistency was present. The magnitude of effect and 95% 

confidence intervals from the two studies in the body evidence varied widely, 

possibly reflecting differences in study methods. 

▪ Evidence type: Very low

GRADE: Death due to COVID-19, Adults and Adolescents (n=2) 

CI: Confidence interval; RR: Risk ratio
Post-COVID-Conditions, Adults and Adolescents

▪ No published or preprint captured in systematic review

▪ Common reasons for exclusion

– Review article 

– Self-reported vaccination status 

– Combines vaccine platforms

– Not a VE study

– Vaccination as a therapeutic (after infection)

▪ Data not captured in the systematic review indicate that COVID-19 vaccine provides 

some protection against post-COVID conditions

48
49 49

Specified Serious Adverse Events (Myocarditis/Pericarditis)

Incidence Rate of Verified Myocarditis/Pericarditis in the 0 to 7 Days After mRNA COVID-19 Vaccination among Persons Aged 12 – 39 Years by Product, 

Age Group, Sex. 

Monovalent Booster Dose Bivalent Booster Dose 

Age group Cases/Doses Administered Incidence Rate/Million Doses 

(95% CI) Cases/Doses Administered Incidence Rate/Million Doses (95% CI)

Pfizer

Male

12-17 y - - 0/55649 0.0 (0.0 – 53.8)

12-15 y 5/81613 61.3 (19.9 – 143.0) - -

16-17 y 9/47874 188.0 (86.0 – 356.9) - -

18-29 y 7/166973 41.9 (16.9 – 86.4) 1/60338 16.6 (0.4 – 92.3)

30-39 y 3/197554 15.2 (3.1 – 44.4) 0/97171 0.0 (0.0 – 30.8)

Female

12-17 y - - 0/57776 0.0 (0.0 – 51.9)

12-15 y 0/84114 0.0 (0.0 – 35.6) - -

16-17 y 2/55004 36.4 (4.4 – 131.3) - -

18-29 y 1/240226 4.2 (0.1 – 23.2) 0/95162 0.0 (0.0 – 31.5)

30-39 y 1/268412 3.7 (0.1 – 20.8) 0/133305 0.0 (0.0 – 22.5)

Moderna

Male

18-29 y 7/109337 64.0 (25.7 – 131.9) 0/22247 0.0 (0.0 – 134.7)

30-39 y 1/149468 6.7 (0.2 – 37.3) 1/41820 23.9 (0.6 – 133.2)

Female

18-29 y 1/156707 6.4 (0.2 – 35.6) 0/35393 0.0 (0.0 – 84.6)

30-39 y 2/191765 10.4 (1.3 – 37.7) 0/55816 0.0 (0.0 – 53.7)

Source: Goddard K, et al. Incidence of Myocarditis/Pericarditis Following mRNA COVID-19 Vaccination Among Children and Younger Adults in the United 

States. Ann Intern Med. 2022;175:1169-1771. Bivalent booster data through March 11, 2023. Data unpublished.
Specified Serious Adverse Events (Anaphylaxis), Adults and 

Adolescents 

▪ Among persons 12 and older, based on events occurring in a 0-1 day risk interval after 

vaccination, the estimated incidence of confirmed anaphylaxis among adolescents and 

adults was:

– 4.8 (95% CI 3.2-6.9) per million doses of Pfizer-BioNTech original monovalent vaccines

– 5.1 (95% CI: 3.3-7.4) per million doses of Moderna original monovalent vaccines

– There were fewer cases of anaphylaxis post dose 2 compared with dose 1

50

Source: Klein et al. Surveillance for Adverse Events After COVID-19 mRNA Vaccination. JAMA. 2021;326(14):1390-1399 
GRADE: Specified Serious Adverse Events , Adults and 

Adolescents 

▪ Observational Studies (n=2)

▪ Two specific, rare SAEs have been associated with vaccination through safety 

surveillance

▪ No serious concerns in certainty assessment.

▪ Evidence type: Low certainty 

51

CI: Confidence interval; RR: Risk ratio; SAE: serious adverse events 
52

Reactogenicity*, Severe (Grade ≥3), Adults and Adolescents 

(n=4)

BLA: Biologics License Application

*Reactogenicity data are from the original monovalent Moderna and Pfizer randomized controlled trials
GRADE: Reactogenicity, Severe (Grade ≥3), Adults and 

Adolescents

▪ Randomized Controlled Trials (n=4)

▪ Pooled RR 4.83 (95% CI: 4.50–5.18) 

▪ Very serious concern for indirectness, as the body of evidence did not include 

anyone who received an updated dose, were from a prior period of the pandemic, 

and excluded persons with prior COVID-19 infection, pregnant or breastfeeding 

women, and persons who were immunocompromised.

▪ Evidence type: Low certainty

53 CI: Confidence interval; RR: Risk ratio
54

Summary of GRADE – Adults and Adolescents

OutcomeImportance Design

(# of studies)

FindingsEvidence

type

Benefits

Medically-attended 

COVID-19 (ED/UC visit) Critical OBS (2) Updated COVID-19 vaccine is effective in preventing medically 

attended COVID-19 ED/UC visits. Low

Hospitalization due to 

COVID-19

Critical OBS (4) Updated COVID-19 vaccine prevents hospitalization due to COVID-19 Low

Death due to COVID-19 Important OBS (2) Updated COVID-19 vaccine prevents death due to COVID-19 Very low

Post-COVID Conditions Important OBS (0) - -

Harms

Serious adverse eventsCritical OBS (2) In post-authorization safety monitoring, myocarditis and anaphylaxis 

were rare but more common following vaccination Low

Reactogenicity Important RCT (4) Severe reactions within 7 days were more common in vaccinated Low

ED: emergency department; UC: urgent care; OBS: observational; RCT: randomized controlled trial
55

Infants and Children Benefits GRADE: 

Adolescent and adult benefits downgraded for indirectness 

▪ Systematic review for benefits of vaccination did not capture a sufficient amount of 

data for evidence synthesis in pediatrics, however data in adults provide indirect 

evidence of benefits

Adolescents and Adults Pediatrics (with indirectness 

downgrade)

OutcomeDesign

(# of studies)

Pooled VE (95% CI) Evidence typeEvidence type

Medically-attended COVID-19 

(ED/UC visit) OBS (2) 53.1 (49.7-56.3) Low Very low

Hospitalization due to COVID19

OBS (4) 47.8 (29.6-61.4) Low Very low

Death due to COVID-19 OBS (2) 60.5 (40.7-73.7) Very low Very low

ED: emergency department; UC: urgent care; OBS: observational 
56

Specified Serious Adverse Events (Myocarditis/Pericarditis), 

Infants and Children

Source: Goddard et al. Incidence of Myocarditis/Pericarditis Following mRNA COVID-19 Vaccination Among Children and Younger Adults in the United 

States. Annals of Internal Medicine. https://www.acpjournals.org/doi/10.7326/M22-2274

▪ A single observational study from the Vaccine Safety Datalink (VSD) evaluated chartreviewed cases of myocarditis occurring among children aged 5-11 years following a 

monovalent booster based on events occurring in a 7-day risk interval after vaccination vs. 

a comparison interval in vaccinated individuals. 

Table. Incidence Rate of Verified Myocarditis/Pericarditis in the 0 to 7 

Days After mRNA COVID-19 Vaccination among Persons Aged 5-11 Years 

by Age Group and Sex. 

Age group

Cases/Monovalent 

Booster Doses 

Administered

Incidence Rate/Million Doses (95% 

CI)

Pfizer

Male

5-11 y 0/50415 0.0 (0.0-59.4)

Female

5-11 y 0/49261 0.0 (0.0-60.8)
Specified Serious Adverse Events (Anaphylaxis), Infants and 

Children

▪ Risk of anaphylaxis in children can be indirectly inferred from the known risk in persons 

ages 12 and older

– 4.8 (95% CI 3.2-6.9) per million doses of Pfizer-BioNTech original monovalent

– 5.1 (95% CI: 3.3-7.4) per million doses of original Moderna monovalent 

– There were fewer cases of anaphylaxis post dose 2 compared with dose 1

Source: Klein et al. Surveillance for Adverse Events After COVID-19 mRNA Vaccination. JAMA. 2021;326(14):1390-1399 57
GRADE: Specified Serious Adverse Events, Infants and Children

▪ Observational Studies (n=2)

▪ Two specific, rare SAEs have been associated with vaccination through safety 

surveillance

▪ Serious concern for indirectness, as the body of evidence for myocarditis was only 

among children aged 5-11 receiving a monovalent booster and the body of 

evidence for anaphylaxis was among adults and adolescents aged 12 years and 

older receiving a primary series

▪ Evidence type: Very low certainty

58 CI: Confidence interval; RR: Risk ratio; SAEs: serious adverse events 
59 59

Reactogenicity*, Severe (Grade ≥3) (n=2), Infants and 

Children

*Reactogenicity data are from the original monovalent Moderna and Pfizer randomized controlled trials. 
GRADE: Reactogenicity, Severe (Grade ≥3) (n=2)

▪ RCTs (n=2)

▪ Pooled RR 4.69 (95% CI: 3.43–6.41) 

▪ Very serious concern for indirectness was present. The available body of evidence 

did not include anyone who received an updated dose and excluded children were 

immunocompromised. While children with a history of COVID-19 infection were 

included in the safety sets, the RCTs were conducted at a time of low 

seroprevalence. 

▪ Evidence type: Low certainty

60

CI: Confidence interval; RR: Risk ratio; RCTs: randomized controlled trials
61 61

Summary of GRADE – Infants and Children

OutcomeImportance Design

(# of studies)

FindingsEvidence

type

Benefits

Medically-attended 

COVID-19 (ED/UC visit) Critical OBS (2)

Updated COVID-19 vaccine is effective in preventing medically 

attended COVID-19 ED/UC visits, although the body of evidence is 

limited to indirect data from adolescents and adults

Very low

Hospitalization due to 

COVID-19

Critical OBS (4)

Updated COVID-19 vaccine prevents hospitalization due to COVID-19, 

although the body of evidence is limited to indirect data from 

adolescents and adults

Very low

Death due to COVID-19 Important OBS (2)

Updated COVID-19 vaccine prevents death due to COVID-19, although 

the body of evidence is limited to indirect data from adolescents and 

adults

Very low

Post-COVID Conditions Important OBS (0) - -

MIS-C Important OBS (0) - -

Harms

Serious adverse eventsCritical OBS (2) In post-authorization safety monitoring, two specific adverse events 

have been associated with vaccination Very Low

Reactogenicity Important RCT (2) Severe reactions within 7 days were more common in vaccinated Low

ED: emergency department; UC: urgent care; OBS: observational; RCT: randomized controlled trial
62

▪ Due to lower uptake of Novavax COVID-19 vaccine, no post-authorization vaccine 

effectiveness estimates from prior COVID-19 vaccine formulation are available

▪ Post-authorization safety data are also limited by the low number of doses 

administered1

– Available data from the Vaccine Adverse Event Reporting System (VAERS) are 

consistent with those from preauthorization clinical trials

– Most VAERS reports were classified as nonserious

• The most commonly reported AEs included dizziness, fatigue, and headache

– No new safety concerns were identified

Novavax vaccine effectiveness and safety

1. https://www.cdc.gov/mmwr/volumes/72/wr/mm7231a4.htm
63 63

103

16

19

75

424

56

51

308

476

76

95

414

0 50 100 150 200 250 300 350 400 450 500

6 months – 4 years

18 – 49 years

5 – 11 years

12 – 17 years

Estimated COVID-19 hospitalizations prevented over 6 months for 

every million mRNA COVID-19 doses, among those age <50 years, by 

age group

Based on hospitalization rates from Spring 2023 (low), December 

2022 (high winter), Summer 2022 (high past year)
64

Calculating Risk: Myocarditis and COVID-19 vaccines

1 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-02/slides-02-24/COVID-02-Shimabukuro-508.pdf

2https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-02-04/11-COVID-Moulia-508.pdf

3https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-02-04/04-COVID-Kracalic-508.pdf

4https://www.cdc.gov/mmwr/volumes/71/wr/mm7114e1.htm?s_cid=mm7114e1_w

▪ Limited data to inform myocarditis risk after bivalent COVID-19 vaccine booster dose 

– Myocarditis rates following booster doses in adolescent and young adult males are lower than rates 

following primary series, but estimates are limited by fewer numbers of doses for both the bivalent 

boosters and the previous monovalent boosters administered in VSD1

▪ Myocarditis risk lower with longer time between doses 

– Rates of myocarditis lower with extended interval between dose 1 and dose 2 for primary series2

– Longer interval between updated doses may also impact myocarditis rates

▪ Most individuals with myocarditis/pericarditis have fully recovered at follow-up3

▪ The risk of adverse cardiac outcomes were 1.8 – 5.6 times higher after SARS-CoV-2 infection than after 

mRNA COVID-19 vaccination among males ages 12-17 years4
65 65

19 – 95 hospitalizations prevented

5 –19 ICU admissions prevented

0 – 1 death prevented

Estimated COVID-19 hospitalizations prevented vs. potential 

myocarditis cases for every million mRNA COVID-19 vaccine doses: 12 

– 17-year-olds1

Per million doses in 12 – 17-year-olds over 6 months2

0 myocarditis3 cases in 55,649 males with a bivalent dose

0 myocarditis3 cases in 57,776 females with a bivalent dose

1 Results were adjusted to account for potential incidental findings of SARS-CoV-2 infection by multiplying the estimated hospitalizations, ICU admissions, and deaths prevented by the estimated 

percent of COVID-NET hospitalizations that are likely due to COVID-19 among 12 – 17-year-olds during on Omicron BA.5 predominant period (55%)

2 Ranges presented for benefits are based on the high and low incidence scenarios presented on slides 7 and 8

3 Based on preliminary Pfizer-BioNTech bivalent booster safety data from VSD (incident rate/million doses): 0 (95% CI: 0-54) in males and 0 (95% CI: 0-52) in females 
66 66

Universal vaccine recommendations projected to prevent about 400,000 

hospitalizations and 40,000 deaths over the next 2 years compared with no 

recommendation, regardless of level of immune escape

https://covid19scenariomodelinghub.org/
67 67

Compared with only vaccinating those 65+ years, universal vaccine recommendations 

projected to prevent about 200,000 more hospitalizations and 15,000 more deaths 

over the next 2 years

https://covid19scenariomodelinghub.org/
Domain Equity Question:

Are the desirable and undesirable anticipated effects 

demonstrated across all populations equally?
▪ There is no evidence to suggest that COVID-19 vaccine effectiveness varies substantially 

by race/ethnicity1,2

– Differences in vaccine hesitancy/uptake, crowding, access to care, and prior infection 

could impact vaccine effectiveness and these factors may also differ by race/ethnicity 

▪ There is no evidence to suggest that COVID-19 vaccine safety profiles vary by 

race/ethnicity, however risk has been shown to differ by age and sex

– Risk for myocarditis is highest in adolescent and young adult males

▪ Benefits and harms for the U.S. population are best assessed when clinical trial and 

study populations are optimally representative of the U.S. population 

Are the desirable and undesirable anticipated effects 

demonstrated across all populations equally?

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9619452/

2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9763212/ 69
▪ Monovalent XBB containing COVID-19 vaccines increase the immune response against the currently 

circulating variants 

▪ Last year’s updated vaccine was effective at preventing medically attended COVID-19, hospitalization 

due to COVID-19, and death due to COVID-19

▪ Accumulating evidence that COVID-19 vaccination reduces Post-COVID Conditions among both children 

and adults

▪ COVID-19 vaccines have a high degree of safety

– Rare events of myocarditis and anaphylaxis have been seen in post-authorization studies 

– Unlikely that updating the formulation would increase adverse event rates

▪ Benefits are anticipated in all age groups; benefits of COVID-19 vaccines vary by age and incidence of 

COVID-19 hospitalizations

▪ Benefits outweigh risks in age groups for which risk of myocarditis is highest

▪ Modeling projects more hospitalizations and deaths averted when updated doses are universally 

recommended compared to no recommendation or recommended only for persons ≥65 years

Summary

Benefits and Harms 

70
Benefits and Harms 

How substantial are the desirable anticipated effects?

• How substantial are the anticipated effects for each main outcome for which 

there is a desirable effect?

o Minimal o Small o Moderate o Large o Varies o Don’t know

Majority opinion Minority opinion
Benefits and Harms 

How substantial are the undesirable anticipated effects?

• How substantial are the anticipated effects for each main outcome for which 

there is an undesirable effect?

o Minimal o Small o Moderate o Large o Varies o Don’t know
Benefits and Harms 

Do the desirable effects outweigh the undesirable effects?

• What is the balance between the desirable effects relative to the 

undesirable effects?

o Favors intervention (2023 – 2024 COVID-19 vaccine)

o Favors comparison (no vaccine)

o Favors both

o Favors neither

o Unclear
EtR Domain:

Values 
75

Americans’ assessment of COVID-19 in the U.S., February 

2023

A nationally representative survey of U.S. adults conducted February 21-28 by web using the Gallup Panel

GALLUP. At Year Three, Americans Split on Whether Pandemic Is Over. https://news.gallup.com/poll/471734/year-three-americans-split-whether-pandemic.aspx Accessed August 

29, 2023

62%

30%

8%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

4/6/20205/6/20206/6/20207/6/20208/6/20209/6/2020

10/6/202011/6/202012/6/2020

1/6/20212/6/20213/6/20214/6/20215/6/20216/6/20217/6/20218/6/20219/6/2021

10/6/202111/6/202112/6/2021

1/6/20222/6/20223/6/20224/6/20225/6/20226/6/20227/6/20228/6/20229/6/2022

10/6/202211/6/202212/6/2022

1/6/20232/6/2023

What’s your impression of the coronavirus situation in the U.S. today?

% Getting better % Staying about the same % Getting worse
76

30% of U.S. adults report they are very or moderately 

concerned about getting COVID-19, August 2023 

A nationally representative sample of U.S. adults aged 18 years and older

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 

10.0 20.0 35.2 34.8

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Overall (N=4,289)

Weighted %

Very concerned Moderately A little Not at all
77

Concern about serious COVID-19 illness in family, March 2023 

Monmouth University. Life Mostly Back to Pre-Covid Normal. Life Mostly Back to Pre-Covid Normal | Monmouth University Polling Institute | Monmouth University Accessed 

August 29, 2023
Domain Equity Question:

Is there important variability in how patients or 

populations value the outcome?
79

Concern about getting COVID-19 by race and ethnicity, August 

2023 

A nationally representative sample of U.S. adults aged 18 years and older

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 

8.8

12.7

18.6

7.8

27.4

22.2

22.1

17.9

36.8

32.6

32.5

36.2

27.0

32.5

26.8

38.1

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Other, non-Hispanic (N=346)

Hispanic (N=629)

Black, non-Hispanic (N=479)

White, non-Hispanic (N=2,835)

Weighted %

Very concerned Moderately A little Not at all
80

Concern about getting COVID-19 by urbanicity, U.S., August 

2023 

A nationally representative sample of U.S. adults aged 18 years and older

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 

10.8

8.4

12.2

17.0

20.3

21.2

35.2

34.5

36.2

37.0

36.9

30.4

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Rural (N=765)

Suburban (N=2,078)

Urban (N=1,446)

Weighted %

Very concerned Moderately A little Not at all
81

Concern about getting COVID-19 by income, August 2023

A nationally representative sample of U.S. adults aged 18 years and older

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 

7.5

9.4

13.3

14.3

19.9

23.0

17.6

19.7

36.8

32.7

34.9

33.6

35.8

34.9

34.2

32.4

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

$75,000+ (N=2,076)

$50,000-$74,999 (N=789)

$25,000-$49,999 (N=801)

$24,999 or less (N=623)

Weighted %

Very concerned Moderately A little Not at all
▪ As of February 2023, the majority of Americans felt COVID-19 was getting better

▪ 30% of U.S. adults report they are very or moderately concerned about getting COVID19 

▪ Half of U.S. adults continue to have concern about a family member becoming seriously 

ill from COVID-19 

▪ Racial and ethnic minority groups, those living in urban areas, and those with lower 

incomes are more concerned about getting COVID-19

Summary

Values
Values

Criteria 1:

Does the target population feel that that the desirable effects are large relative 

to undesirable effects?

• How does the target population view the balance of desirable versus undesirable 

effects?

• Would patients/caregivers feel that the benefits outweigh the harms and burden?

• Does the population appreciate and value the 2023 – 2024 COVID-19 vaccine?

o Minimal o Small o Moderate o Large o Varies o Don’t know

Majority opinion Minority opinion
Values

Criteria 2:

Is there important uncertainty about, or variability in, how much people value 

the main outcomes?

• How much do individuals value each outcome in relation to the other outcomes?

• Is there evidence to support those value judgements?

• Is there evidence that the variability is large enough to lead to different decisions?

oImportant uncertainty or variability

oProbably important uncertainty or variability

oProbably not important uncertainty or variability

oNo important uncertainty or variability

oNo known undesirable outcomes

Minority opinion

Majority opinion
EtR Domain:

Acceptability
86

Intent to get new, updated COVID-19 vaccine, August 2023 

A nationally representative sample of U.S. adults aged 18 years and older

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 

24.9 17.6 18.2 13.6 25.7

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Overall (N=4,283)

Weighted %

Definitely will get vaccine Probably will Unsure Probably will not Definitely will not
87 87

Bivalent COVID-19 vaccine receipt and intent among adults 18 

years and older, June 2023 

A nationally representative sample of U.S. adults aged 18 years and older 

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from June 2023 (N=4,214), unpublished data 

44.7 3.4

10.5

23.8

88

28.1

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Among unvaccinated (N=783)

Among 1+ vaccinated (N=3,248)

Received bivalent COVID-19 vaccine Definitely will get vaccine

Probabaly will get vaccine or unsure Probably/definitely will not get vaccine
88 88

Top concerns or issues regarding bivalent COVID-19 vaccine, 

June 2023

A nationally representative sample of U.S. adults aged 18 years and older 

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from June 2023 (N=4,214), unpublished data 

Received 1+ doses of COVID-19 vaccine 

but not the bivalent vaccine

Unvaccinated with any COVID-19 

vaccine

Definitely will • Too busy or kept forgetting (36.3%) Omitted (N<30)

Probably will or unsure • Had enough vaccines (27%)

• Too busy or kept forgetting (22.2%)

• No provider recommendation (19.8%)

• Unknown serious side effects (12.8%)

• Unknown serious side effects (37.1%)

Probably or definitely will NOT • Unknown serious side effects (43.1%)

• Had enough vaccines (42.4%)

• Not enough studies (33.8%)

• Do not trust gov’t/pharma (30%)

• Effectiveness (29.8%)

• Heart-related issues (28.6%)

• Unknown serious side effects (56.5%)

• Do not trust gov’t/pharma (50.5%)

• Not enough studies (47.1%)

• Heart-related issues (39.6%)

• Effectiveness (36.1%)
89 89

Confidence in vaccine safety is higher for influenza and other 

routine adult vaccines than for COVID-19 vaccine, June 2023 

Analysis limited to those who responded to all three survey questions (N=4,164). Omitted category of respondents who answered “not sure” is <1%.

A nationally representative sample of U.S. adults aged 18 years and older 

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from June 2023 (N=4,214), unpublished data 

30.8

34.3

23.8

34.8

29.5

25.5

27.3

26.4

29.9

7.2

9.8

20.8

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Routine Adult Vaccines

Flu Vaccine

COVID-19 Vaccine

Vaccine is completely safe Very safe Somewhat safe Not at all safe
90 90

Vaccine recommendation by healthcare provider 

(among those eligible to receive the vaccine), June 2023

A nationally representative sample of U.S. adults aged 18 years and older 

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from June 2023 (N=4,214), unpublished data 

72.2

63.3 62.2

57.3 56.2

0

10

20

30

40

50

60

70

80

Flu (N=4,169) Shingles (N=2,144) Pneumonia (N=1,851) Tetanus (N=4,158) COVID-19 (N=4,171)

Percent reporting HCP recommendation

Axis Title
91 91

Vaccine receipt by healthcare provider recommendation 

(among those eligible to receive the vaccine), June 2023

A nationally representative sample of U.S. adults aged 18 years and older 

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from June 2023 (N=4,214), unpublished data 

9.4

53.2

11.9

51.7

63.4

70.7

94.3

81.3

89.1

89.2

0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 80.0 90.0 100.0

Shingles

Tetanus

Pneumonia

Flu

COVID-19

Provider recommendation No provider recommendation

(N=2,419)

(N=1,752)

(N=3,083)

(N=1,086)

(N=2,489)

(N=1,669)

(N=1,393)

(N=751)

(N=658)

(N=1,193)
▪ Data from the Fall 2022 DocStyles survey were analyzed to examine the prevalence of COVID-19 

vaccination attitudes and practices among health care providers (HCPs) caring for women of 

reproductive age, and to assess whether providers recommended and offered or administered the 

COVID-19 vaccines to their pregnant patients 

▪ Overall, 82.9% of providers reported recommending COVID-19 vaccination to women of reproductive 

age, and 54.7% offered or administered the vaccine in their practice

▪ Among HCPs who cared for pregnant patients, obstetrician-gynecologists were more likely to 

recommend COVID-19 vaccination to pregnant patients (94.2%) than were family practitioners/internists 

(82.1%) 

▪ HCPs were more likely to offer or administer COVID-19 vaccination onsite to pregnant patients if they 

also offered or administered influenza and Tdap vaccines 

COVID-19 vaccine recommendation and administration by 

U.S. health care providers among women of reproductive age 

Fall 2022 DocStyles, unpublished data (data will be published in MMWR on September 28, 2023) 92
Domain Equity Question:

Is the intervention equally acceptable across all 

populations?
94 94

COVID-19 vaccine safety confidence by race and ethnicity, 

August 2023

A nationally representative sample of U.S. adults aged 18 years and older

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 

20.6

22.3

18.9

23.2

32.2

26.3

24.6

24.9

32.7

30.5

36.3

28.6

14.5

20.9

20.2

23.3

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Other, non-Hispanic (N=347)

Hispanic (N=626)

Black, non-Hispanic (N=476)

White, non-Hispanic (N=2,830)

Weighted %

Vaccine is completely safe Very safe Somewhat safe Not at all safe
95 95

COVID-19 vaccine safety confidence by income, August 2023 

A nationally representative sample of U.S. adults aged 18 years and older

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 

26.9

21.2

18.1

14.7

29.7

26.0

20.1

20.5

25.5

30.6

37.1

35.7

17.8

22.2

24.7

29.1

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

$75,000+ (N=2,075)

$50,000-$74,999 (N=788)

$25,000-$49,999 (N=797)

$24,999 or less (N=619)

Weighted %

Vaccine is completely safe Very safe Somewhat safe Not at all safe
96 96

COVID-19 vaccine safety confidence by urbanicity, August 

2023 

A nationally representative sample of U.S. adults aged 18 years and older

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 

16.4

23.1

24.4

20.2

27.0

27.0

33.4

29.4

29.6

30.0

20.5

19.0

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Rural (N=762)

Suburban (N=2,075)

Urban (N=1,442)

Weighted %

Vaccine is completely safe Very safe Somewhat safe Not at all safe
97

Intent to get new, updated COVID-19 vaccine by age, August 

2023

A nationally representative sample of U.S. adults aged 18 years and older

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 

43.1

28

15.8

18.6

19.4

16.3

13.1

16.2

21.2

9.1

11.8

16.3

16

24.5

30.3

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Age 65+ (N=1,091)

Age 50-64 (N=1,109)

Age 18-49 (N=2,083)

Weighted %

Definitely will get vaccine Probably will Unsure Probably will not Definitely will not
98 98

Percent of people receiving COVID-19 vaccine by age

*Data cutoff on May 10, 2023 is due to the end of the Public Health Emergency (PHE) on May 11, 2023

Data source: VTrcks, IIS, Federal Pharmacy Program, Federal Entities Program, U.S. Census Bureau 10-year July 2019 National Population Estimates

https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends. Accessed 9/5/2023

December 14, 2020 – May 10, 2023*
99

Intent to get new, updated COVID-19 vaccine by race and 

ethnicity, August 2023

A nationally representative sample of U.S. adults aged 18 years and older

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from August 2023 (N=4,299), unpublished data 

21.8

22.2

27.9

25.5

19.5

21.7

17

16.3

22.7

22.1

19.4

16.2

17.1

11.6

14

13.6

18.9

22.4

21.7

28.5

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Other, non-Hispanic (N=347)

Hispanic (N=626)

Black, non-Hispanic (N=478)

White, non-Hispanic (N=2,832)

Weighted %

Definitely will get vaccine Probably will Unsure Probably will not Definitely will not
10

0

100

Estimated percent of people ≥ 18 years reporting COVID-19 

vaccination by race/ethnicity

Source: National Immunization Survey Adult COVID Module. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends. Accessed 9/5/2023

National Immunization Survey Adult COVID Module, April 22, 2021 – March 25, 2023
10

1

101

COVID-19 vaccine receipt by healthcare provider 

recommendation by race and ethnicity, June 2023 

A nationally representative sample of U.S. adults aged 18 years and older 

IPSOS KnowledgePanel and NORC AmeriSpeak Omnibus Surveys, results from June 2023 (N=4,214), unpublished data 

66.1

64.1

65.2

62.4

94.5

89

83.6

89.4

0 10 20 30 40 50 60 70 80 90 100

Other, non-Hispanic

Hispanic

Black, non-Hispanic

White, non-Hispanic

Provider recommendation No provider recommendation

(N=1,102)

(N=1,690)

(N=253)

(N=220)

(N=306)

(N=298)

(N=170)

(N=132)
10

2

102

Percent of pregnant people ages 18-49 years who are up to date* with 

COVID-19 vaccines overall and by race and ethnicity – Vaccine Safety 

Datalink, September 1, 2022 – July 29, 2023

*Up to date is defined as the percent of pregnant people who received an updated bivalent dose before or during pregnancy, with the denominator including those pregnant at 

least 1 day during the specified month ending date, and the numerator including those who received an updated bivalent dose. CDC recommended bivalent boosters to persons 

age ≥12 years starting September 1, 2022. Data on bivalent boosters among pregnant persons was available starting September 4, 2022, and includes doses received starting 

September 1, 2022

CDC. COVID-19 vaccination among pregnant people aged 18-49 years overall, by race and ethnicity, and date reported to CDC – Vaccine Safety Datalink,* United States. 

https://covid.cdc.gov/covid-data-tracker/#vaccinations-pregnant-women Accessed August 9, 2023
▪ Vaccine receipt varies by age and race/ethnicity

▪ Fall vaccination intent increases with increasing age; those ages 65+ have the highest 

percentage reporting they “definitely” or “probably” will get the vaccine compared to 

other age groups 

▪ Confidence in COVID-19 vaccine safety differs across the population

▪ Compared to other vaccines, COVID-19 vaccines were recommended the least by 

health care providers 

▪ Those who received a provider recommendation overall and by race and ethnicity were 

more likely to receive the recommended vaccine

▪ Encouraging health care providers to recommend, offer, and administer COVID-19 

vaccines, could help reinforce vaccine confidence and increase coverage1

Summary

Acceptability 

103

1. Fall 2022 DocStyles, unpublished data
Acceptability

Is the 2023 – 2024 COVID-19 vaccine acceptable to key stakeholders?

• Are there key stakeholders that would not accept the distribution of benefits 

and harms?

• Are there key stakeholders that would not accept the undesirable effects in 

the short term for the desirable effects (benefits) in the future?

oNo oProbably no oProbably yes oYes oVaries oDon’t know

Majority opinion Minority opinion
EtR Domain:

Feasibility 
▪ Vaccines with a monovalent XBB.1.5 composition will be the first COVID-19 vaccines to 

be available directly from the manufacturers as part of the commercial market, rather 

than through the United States Government (USG)

▪ The public will continue to be directed to Vaccines.gov to find providers offering COVID19 vaccine

▪ While providers will no longer be required to report inventory to Vaccines.gov after 

vaccines transition to being available on the commercial market, they will continue to 

be encouraged to report voluntarily

– Providers are also strongly encouraged to report the minimum age (in months and 

years) for whom a location can administer vaccine

▪ CDC will continue its efforts to make sure that all people have access to COVID-19 

medical countermeasures and know where to find product now and in the future 

Fall COVID-19 vaccine transition 

CDC. HHS Commercialization Transition Guide: Sunsetting the US Government COVID-19 Vaccine Distribution Program. https://www.cdc.gov/vaccines/covid-19/downloads/HHSCommercialization-Transition-Guide-508.pdf Accessed August 4, 2023 106
▪ Inclusion of COVID-19 vaccines in Vaccines for Children (VFC) will likely result in more pediatricians 

stocking the vaccine 

▪ There will be single dose vial presentations and smaller minimum order quantities 

– Directly addresses concerns from health care providers (HCPs), likely to reduce wastage, eases logistics 

and helps with storage capacity limitations

• Moderna, 12+ years: single dose vial (10-pack) and manufacturer-prefilled syringes (10-pack)

• Moderna, 6 months – 11 years: single dose vial (10-pack)

• Novavax, 12+ years: 5-dose multi-dose vial (2 vials per carton)

• Pfizer, 12+ years: single dose vial (10-pack), limited quantity of manufacturer-prefilled syringes (10-

pack)

• Pfizer, 5 – 11 years: single dose vial (10-pack)

• Pfizer, 6 months – 4 years: 3-dose multi-dose vial (10-pack)

▪ Preparation is the same or simpler than it was before

– Moderna preparation is the same (no dilution)

– Novavax preparation is the same (no dilution)

– Pfizer preparation is simplified (currently 2 presentations require dilution; for 2023 – 2024 COVID-19 

vaccine, ONLY little peds formulation require dilution) 

Feasibility of vaccine implementation

Immunization Services Division, internal planning documents 
▪ Storage and handling will be the SAME as it is now

– Moderna: Frozen until expiration; 30 days at refrigerator storage

– Novavax: Stable at 2-8°C (refrigerator storage); 9-month shelf life; use within 12 hours 

of first puncture

– Pfizer: Ultra-cold storage until expiration; 10 weeks at refrigerator storage

• Ultra-cold storage continues to be a challenge; most provider offices do not have a 

unit 

▪ Dose volume for Pfizer is simplified (all doses are 0.3mL) 

▪ Moderna now only has two presentations, reducing the chance for errors

Feasibility of vaccine implementation, cont’d

Immunization Services Division, internal planning documents 
▪ There are now THREE seasonal vaccines and preventative products1

for respiratory 

diseases to manage

– More seasonal vaccines to manage 

– Limited storage space and more vaccines

– More opportunities for vaccine administration errors 

▪ Providers have to adapt to new cap/label colors

– Moderna: 6 months – 11 years is blue cap/green label; 12+ years is blue cap/blue

label

– Novavax: 12+ is blue

– Pfizer: 6 months – 4 years is yellow; 5 – 11 years is blue; 12+ years is gray

▪ Moderna, Novavax and Pfizer all have products with blue caps, introducing opportunity 

for error

Barriers to implementation

1 COVID-19 vaccine, Influenza vaccine, RSV vaccine, and nirsevimab, a long-acting monoclonal antibody for RSV prevention in infants

Immunization Services Division, internal planning documents 
Domain Equity Question:

Is the intervention equally feasible to implement 

across all populations?
11

1

111

There are disparities in uninsured status that could impact 

who gets a COVID-19 vaccine

0%

5%

10%

15%

20%

25%

White Black American Indian

and Alaska Native

Asian Native Hawaiian

and Other Pacific

Islander

Hispanic or Latino

Percent of US adults without health insurance

U.S. Census Bureau, 2021 American Community Survey 1-year estimates: https://data.census.gov/table?q=race&t=Health+Insurance&tid=ACSST1Y2021.S2701
▪ CDC will provide access to COVID-19 vaccines for uninsured individuals once COVID-19 

vaccines become commercially available1

▪ Uninsured children will be able to receive COVID-19 vaccines through the existing 

Vaccines for Children (VFC) program1

– The VFC program offers vaccines at no low or no cost to eligible children through a national network of 

participating health care providers2

▪ Adults who are uninsured or underinsured will be able to receive no-cost COVID-19 

vaccines through the temporary Bridge Access Program for COVID-19 Vaccines. This 

program consists of two components:

– Public health infrastructure: through state immunization programs, State and local health departments and HRSAsupported health centers will provide no-cost COVID-19 vaccines to adults who are uninsured or underinsured

– Participating retail pharmacies: CVS, Walgreens, and eTrueNorth will continue to provide no-cost COVID-19 

vaccines to adults who are uninsured or underinsured3

CDC vaccine programs for people who are uninsured

1. CDC. HHS Commercialization Transition Guide: Sunsetting the US Government COVID-19 Vaccine Distribution Program. https://www.cdc.gov/vaccines/covid19/downloads/HHS-Commercialization-Transition-Guide-508.pdf Accessed August 4, 2023

2. CDC. VFC Information for Parents. https://www.cdc.gov/vaccines/programs/vfc/parents/index.html Accessed August 30, 2023

3. CDC. Bridge Access Program for COVID-19 Vaccines. https://www.cdc.gov/vaccines/programs/bridge/index.html Accessed September 7, 2023 112
▪ CDC's Bridge Access Program for COVID-19 Vaccines and COVID-19 vaccine 

implementation plans are intentionally designed to overcome barriers to access and 

availability

– This includes design for maximized proximity to no-cost COVID-19 vaccines among 

populations of people who are uninsured or underinsured

▪ CDC and HHS continue to invest in health systems and programs that support vaccine 

access and outreach in underserved communities – such as HRSA-Supported Health 

Centers, Rural Health Clinics, and State and local health departments

– These networks can be leveraged for access to COVID-19 vaccines as well as other 

needed medicines

Availability of vaccines in underserved communities 

ASPR Administration for Strategic Preparedness & Response. Commercialization of COVID-19 Medical Countermeasures. https://aspr.hhs.gov/COVID-19/Pages/FAQCommercialization.aspx Accessed August 25, 2023 113
▪ Implementation of the 2023 – 2024 COVID-19 vaccine will likely reduce wastage, ease 

logistics, help with storage capacity limitations and reduce the chance of errors

▪ Nevertheless, there will be now be three seasonal vaccines for respiratory diseases, in 

which there will be more seasonal vaccines to manage, limited storage space due to 

additional vaccines and more opportunities for vaccine administration errors

▪ Vaccines will continue to be accessible after commercialization, with readily available 

resources for those who are uninsured, underinsured, or who reside in underserved 

communities

Summary

Feasibility 

114
Feasibility

Is the 2023 – 2024 COVID-19 vaccine feasible to implement among 

populations currently recommended for a dose?

• Is the 2023 – 2024 COVID-19 vaccine program sustainable?

• Are there barriers that are likely to limit the feasibility of implementing the 2023 –

2024 COVID-19 vaccine or require considerations when implementing it?

• Is access to the 2023 – 2024 COVID-19 vaccine an important concern?

oNo oProbably no oProbably yes oYes oVaries oDon’t know
EtR Domain:

Resource Use 
▪ COVID-19 vaccination is a cost – effective intervention, particularly in persons ages ≥65 

years in which the vaccine is cost saving

▪ Cost-effectiveness estimates in those ages ≥50 years were robust to input changes 

across plausible ranges

▪ Cost-effectiveness estimates in those 18-49 years were sensitive to changes in inputs

– If vaccine effectiveness or hospitalization rates are higher than anticipated, the costeffectiveness estimates would be more favorable

▪ Cost-effectiveness estimates are not yet available for pediatric population

Summary

117
Domain Equity Question:

Is the intervention a reasonable and efficient 

allocation of resources across all populations?
▪ COVID-19 vaccination is most cost-effective in older adults in which disease burden is 

highest compared to younger adults

▪ COVID-19 vaccination is likely more cost-effective in populations with risk factors, such 

as underlying conditions, which increase their probability of hospitalization due to 

COVID-19 

▪ Additional work is ongoing to evaluate cost-effectiveness in the pediatric populations

Is the intervention a reasonable and efficient allocation of 

resources across all populations?

119
Resource Use

Is the 2023 – 2024 COVID-19 vaccine a reasonable and efficient allocation of 

resources?

• What is the cost-effectiveness of the 2023 – 2024 COVID-19 vaccine?

• How does the cost-effectiveness of the 2023 – 2024 COVID-19 vaccine change in 

response to changes in context, assumptions, etc.?

oNo oProbably no oProbably yes oYes oVaries oDon’t know

Majority opinion Minority opinion
Summary and Work Group Interpretations 
▪ The burden of COVID-19 varies by age and underlying condition status with those ages ≥65 years and 

those with multiple underlying conditions having the highest risk of severe outcomes due to COVID-19

▪ COVID-19 burden is currently lower than at previous points in the pandemic, however there are still 

thousands of hospitalizations and hundreds of deaths each week

▪ Children and adults ages 5 – 49 years had the lowest hospitalization rates overall

– Severe outcomes occur in this age group, including in people with no underlying medical conditions

▪ Although hospitalization rates are currently low, we have seen rates increase in recent weeks and 

anticipate further increases as we enter respiratory virus season

▪ Majority of U.S. population has some level of immunity due to infection, vaccination, or both

– Vaccine and infection-induced immunity wane and new variants have emerged, suggesting that

susceptibility remains and may increase over time

▪ Racial and ethnic minority groups have been disproportionately affected by COVID-19

Summary and Work Group Interpretation: 

Public Health Burden

122
▪ Monovalent XBB containing COVID-19 vaccines increase the immune response against the currently 

circulating variants 

▪ Last year’s updated vaccine was effective at preventing medically attended COVID-19, hospitalization 

due to COVID-19, and death due to COVID-19

▪ COVID-19 vaccines have a high degree of safety

– Unlikely that updating the formulation would increase adverse event rates

▪ Benefits are anticipated in all age groups; benefits of COVID-19 vaccines vary by age, and incidence of 

COVID-19 hospitalizations

▪ Benefits outweigh risks in age groups for which there is a risk of myocarditis

▪ Modeling projects more hospitalization and deaths averted when updated doses are universally 

recommended compared to no recommendation or recommended only for persons ≥65 years

Summary and Work Group Interpretation:

Benefits and Risks

123
▪ Work Group considered non-universal policy options, with considerable discussion around the magnitude of benefits in 

the young, healthy population

▪ As part of these deliberations, Work Group requested additional data on severe illness due to COVID-19 in those with 

and without underlying conditions

– No group that clearly had no risk of severe illness

– The vast majority of the US population has an underlying condition that would qualify under a risk based 

recommendation

• Prevalence of overweight and obesity alone is >70% of adults1

– Risk based recommendation would not allow access to COVID-19 vaccines for all that wanted them 

▪ Shared clinical decision making could create barriers to vaccination and may not effectively target those at highest risk

▪ COVID-19 epidemiology remains uncertain and non-universal recommendations would need to be quickly revisited if 

there was an increase in burden

▪ Still substantial COVID-19 disease burden and simple, stable recommendations may increase vaccine coverage over time

▪ Work Group emphasized that COVID-19 recommendations should be reviewed on an ongoing basis as more is learned 

about COVID-19 seasonality and disease burden in the future

Summary and Work Group Interpretation:

Considerations Regarding a Universal vs. Non-universal Policy

1National Health Statistics Reports; https://stacks.cdc.gov/view/cdc/106273

124
▪ Burden of severe illness due to COVID-19 is lowest among children ages 5 – 17 years

▪ Despite lower burden relative to other age groups, hundreds of deaths due to COVID-19 occurred in this 

age group in 2021 and 2022

– Half of pediatric COVID-19 deaths were in individuals with no underlying conditions

▪ Number of COVID-19 hospitalizations and deaths in this age group are comparable to the burden seen in 

other vaccine preventable diseases for which there are universal recommendations

▪ Potential additional benefits of vaccination, such as prevention of post-COVID conditions and potential 

for reduced school absenteeism 

▪ Risk of myocarditis appears lower than the risk observed following primary series doses

– Potentially lower due to increased interval between doses

– Certainty is limited by relatively lower sample size of booster recipients in VSD

▪ Future COVID-19 epidemiology remains uncertain and the low disease burden we are currently seeing 

may not last

▪ After a robust discussion, Work Group was supportive of a universal recommendation at this time

Summary and Work Group Interpretation: 

COVID-19 vaccine recommendations for children 

125
126

EtR DomainQuestionWork Group Judgments

Public Health 

Problem

Is COVID-19 of public health importance?Yes

Benefits and Harms

How substantial are the desirable anticipated effects? Large

How substantial are the undesirable anticipated effects? Small

Do the desirable effects outweigh the undesirable effects? Favors intervention

Values

Does the target population feel the desirable effects are large 

relative to the undesirable effects?

Moderate 

Is there important variability in how patients value the 

outcomes?

Probably important 

uncertainty or variability

Acceptability

Is the 2023-2024 COVID-19 vaccine acceptable to key 

stakeholders?

Yes / Probably yes / Varies

FeasibilityIs the 2023-2024 COVID-19 vaccine feasible to implement?Yes

Resource Use

Is the 2023-2024 COVID-19 vaccine a reasonable and efficient 

allocation of resources?

Yes
127

Evidence to Recommendations Framework

Summary: Work Group Interpretations 

Balance of 

consequences

Undesirable 

consequences 

clearly 

outweigh 

desirable 

consequences 

in most 

settings

Undesirable 

consequences 

probably 

outweigh 

desirable 

consequences 

in most 

settings

The balance 

between 

desirable and 

undesirable 

consequences 

is closely 

balanced or 

uncertain

Desirable 

consequences 

probably 

outweigh 

undesirable 

consequences 

in most 

settings

Desirable 

consequences 

clearly 

outweigh 

undesirable 

consequences 

in most 

settings

There is 

insufficient 

evidence to 

determine the 

balance of 

consequences

Majority opinion Minority opinion
128

Evidence to Recommendations Framework

Summary: Work Group Interpretations 

Type of 

recommendation

We do not recommend 

the intervention

We recommend the 

intervention for individuals 

based on shared clinical 

decision-making

We recommend the 

intervention 
ACIP recommends 2023–2024 (monovalent, XBB containing) 

COVID-19 vaccines as authorized under Emergency Use 

Authorization (EUA) or approved by Biologics License Application 

(BLA) in persons ≥6 months of age

Proposed ACIP Voting Language

129
Clinical Considerations

130
▪ Everyone ages 5 years and older is recommended to receive 1 dose of a 2023–2024 

mRNA COVID-19 vaccine

▪ Children ages 6 months–4 years should complete a multi-dose initial series (2 doses of 

Moderna or 3 doses of Pfizer-BioNTech mRNA COVID-19 vaccine) with at least one dose 

of the 2023–2024 COVID-19 vaccine1

▪ People who are moderately or severely immunocompromised should complete a 3-

dose initial series with at least one dose of the 2023–2024 COVID-19 vaccine and may 

receive 1 or more additional 2023–2024 COVID-19 vaccine doses2

▪ Bivalent mRNA COVID-19 vaccines are no longer recommended in the United States

Proposed 2023 – 2024 mRNA COVID-19 vaccine 

recommendations:

1. Children ages 6 months – 4 years that previously received a single dose of Pfizer-BioNTech vaccine should receive 2 doses of Pfizer-BioNtech vaccine. 

2. Additional details in the interim clinical considerations 131
Bivalent recommendations Proposed 2023 – 2024 

vaccine recommendations

Rationale

Everyone ages 6 years and 

older recommended for a 

single bivalent dose

Everyone ages 5 years and 

older recommended for a 

single 2023 – 2024 dose

Eliminates complex 

recommendations for 5-yearolds

Two Moderna dosages 

authorized for 6 months – 5 

years, depending on 

vaccination history and 

immune status

All Moderna doses in ages 6 

months – 11 years are now 25 

μcg

Reduces the number of 

COVID-19 vaccine products in 

use

Optional 2nd bivalent dose for 

those ages 65 years and older

No additional dose 

recommendation at this time

Will monitor epidemiology 

and vaccine effectiveness to 

determine if additional doses 

are needed

Key changes from bivalent mRNA recommendations
Acknowledgements

133

▪ Monica Godfrey

▪ Danielle Moulia

▪ Hannah Rosenblum

▪ Katherine Fleming-Dutra

▪ Ruth Link-Gelles

▪ Sarah Meyer

▪ Elisha Hall

▪ Joanna Regan 

▪ Susan Goldstein

▪ Mary Chamberland

▪ JoEllen Wolicki

▪ Josephine Mak

▪ Morgan Najdowski

▪ Lauren Roper

▪ Karen Broder 

▪ Melisa Shah

▪ Mehreen Meghani

▪ Romeo Galang

▪ Sascha Ellington 

▪ Sierra Scarbrough

▪ Amadea Britton

▪ Jefferson Jones

▪ Aron Hall

▪ Barbara Mahon

▪ COVID-NET

▪ COVID-19 Scenario Modeling Hub

▪ University of Michigan COVID-19 Vaccination Modeling 

Team

▪ Immunization Safety Office

▪ Immunization Services Division

▪ Coronavirus and other Respiratory Viruses Division

▪ National Center for Immunization and Respiratory 

Diseases
For more information, contact CDC

1-800-CDC-INFO (232-4636)

TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the official 

position of the Centers for Disease Control and Prevention.

Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation 

use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.

Thank you 
Additional Clinical Considerations 
Proposed recommendations for children aged 6 

months–4 years who are not moderately or 

severely immunocompromised
▪ All doses should be homologous (i.e., from the same manufacturer) 

▪ All Moderna doses in ages 6 months – 11 years are now 25 μcg 

Proposed recommendations for children aged 6 months – 4 years 

without immunocompromise

Doses recommended:

▪ Initial series of 2 Moderna vaccine doses OR 3 

Pfizer-BioNTech vaccine doses 

▪ At least 1 dose of 2023–2024 COVID-19 vaccine 
Vaccinated

1 dose any 

PfizerBioNTech

2 doses any 

PfizerBioNTech

3 or more 

doses any 

PfizerBioNTech

2023–2024 

Moderna

2 doses

2023–2024 

PfizerBioNTech

3 doses

0.25 mL/25 μg 0.3 mL/3 μg

Previously received 

COVID-19 vaccine(s)

Recommendations 

for 2023–2024 

vaccine, by 

manufacturer

Unvaccinated

OR

2023–2024 

Moderna

1 dose

0.25 mL/25 μg

2023–2024 

PfizerBioNTech

2 doses

0.3 mL/3 μg

2023–2024 

PfizerBioNTech

1 dose

0.3 mL/3 μg

Proposed recommended 2023–2024 COVID-19 mRNA vaccines for people who are NOT immunocompromised, 

aged 6 months–4 years*

1 dose any 

Moderna

2 or more 

doses any 

Moderna

*For information about administration intervals and people who transition from age 4 years to age 5 years during an mRNA vaccination series, see Table 1 in the 

Interim Clinical Considerations for Use of COVID-19 vaccines.

COVID-19 vaccination 

status as of 

September 2023
Proposed recommendations for people aged 5 

years and older who are not moderately or 

severely immunocompromised
Proposed recommendations for people aged 5 years and older 

without immunocompromise 

Doses recommended:

• 1 dose of 2023–2024 COVID-19 vaccine, 

regardless of prior vaccination history

▪ New harmonized age cutoff for recommendations for young children for Moderna and 

Pfizer-BioNTech COVID-19 vaccines

▪ Resulting in simplified recommendations for 5-year-olds

▪ All Moderna doses in ages 6 months – 11 years are now 25 μcg 

▪ 2023–2024 COVID-19 vaccine dose is recommended at least 2 months after receipt of 

the last COVID-19 vaccine dose
Vaccinated

Previously received 

COVID-19 vaccine(s)

Recommendations 

for 2023–2024 

vaccine, by 

manufacturer

Unvaccinated

2023–2024 

Moderna

1 dose

0.25 mL/25 μg

2023–2024 

PfizerBioNTech

1 dose

0.3 mL/10 μg

Proposed recommended 2023–2024 COVID-19 mRNA vaccines for people who are NOT immunocompromised, 

aged 5–11 years*

1 or more 

doses any 

mRNA

*For information about administration intervals and people who transition from age 4 years to age 5 years during an mRNA vaccination series, see Table 1 in the 

Interim Clinical Considerations for Use of COVID-19 vaccines.

OR

COVID-19 vaccination 

status as of 

September 2023
Previously received 

COVID-19 vaccine(s)

Recommendations 

for 2023–2024 

vaccine, by 

manufacturer

Unvaccinated

2023–2024 

Moderna

1 dose

0.5 mL/50 μg

2023–2024 

PfizerBioNTech

1 dose

0.3 mL/30 μg

Proposed recommended 2023–2024 COVID-19 mRNA vaccines for people who are NOT immunocompromised, aged ≥12 years*

1 or more 

doses any 

mRNA

Vaccinated

1 or more doses Novavax 

or Janssen, including in 

combination with any 

mRNA vaccine dose(s)

*For information about administration intervals, see Table 1 in the Interim Clinical Considerations for Use of COVID-19 vaccines.

OR

COVID-19 vaccination 

status as of 

September 2023
Proposed recommendations for people who are 

moderately or severely immunocompromised
Proposed recommendations for people aged ≥6 months who are 

moderately or severely immunocompromised

Doses recommended:

▪ Initial COVID-19 vaccine series*

▪ At least 1 2023–2024 COVID-19 vaccine dose

▪ May receive 1 or more additional 2023-2024 

mRNA COVID-19 vaccine doses**

*Series of 3 homologous mRNA COVID-19 vaccine doses at time of initial vaccination. This could also include 

a history of receipt of 1 or more doses of Novavax or Janssen, including in combination with mRNA vaccine 

dose(s). 

**Further additional dose(s) may be administered, informed by the clinical judgement of a healthcare 

provider and personal preference and circumstances. Further additional doses should be administered at 

least 2 months after the last 2023-2024 COVID-19 vaccine dose. 
1 dose any 

PfizerBioNTech

2 doses any 

PfizerBioNTech

3 or more 

doses any 

PfizerBioNTech

2023–2024 

Moderna

3 doses

2023–2024 

PfizerBioNTech

3 doses

0.25 mL/25 μg 0.3 mL/3 μg

COVID-19 vaccination 

status as of 

September 2023

Previously received 

COVID-19 vaccine(s)

Recommendations 

for 2023–2024 

vaccine, by 

manufacturer

Unvaccinated

2023–2024 

Moderna

2 doses

0.25 mL/25 μg

2023–2024 

PfizerBioNTech

2 doses

0.3 mL/3 μg

2023–2024 

PfizerBioNTech

1 dose

0.3 mL/3 μg

Proposed recommended 2023–2024 COVID-19 vaccines for people who ARE moderately or severely immunocompromised, 

aged 6 months–4 years* 

1 dose any 

Moderna

2023–2024 

Moderna

1 dose

0.25 mL/25 μg

Vaccinated

2 doses any 

Moderna

3 or more 

doses any 

Moderna

*For information about administration intervals, people who transition from age 4 years to age 5 years during an mRNA vaccination series, and administration 

of additional dose(s), see Table 2 in Interim Clinical Considerations for Use of COVID-19 Vaccines. 

OR
2023–2024 

Moderna

3 doses

0.25 mL/25 μg

Previously received 

COVID-19 vaccine(s)

Recommendations 

for 2023–2024 

vaccine, by 

manufacturer

Unvaccinated

2023–2024 

Moderna

2 doses

0.25 mL/25 μg

Proposed recommended 2023–2024 COVID-19 vaccines for people who ARE moderately or severely immunocompromised, 

aged 5–11 years*

2 doses any 

Moderna

2023–2024 

Moderna

1 dose

0.25 mL/25 μg

2023–2024 

PfizerBioNTech

2 doses

0.3 mL/10 μg

2023–2024 

PfizerBioNTech

1 dose

0.3 mL/10 μg

1 dose any 

Moderna

1 dose any 

PfizerBioNTech

2 doses any 

PfizerBioNTech

3 or more doses 

any mRNA 

vaccine

Vaccinated

*For information about administration intervals, people who transition from age 4 years to age 5 years or age 11 years to age 12 years during an mRNA 

vaccination series, and administration of additional dose(s), see Table 2 in Interim Clinical Considerations for Use of COVID-19 Vaccines. 

OR

2023–2024 

PfizerBioNTech

3 doses

0.3 mL/10 μg

OR

2023–2024 

PfizerBioNTech

1 dose

0.3 mL/10 μg

2023–2024 

Moderna

1 dose

0.25 mL/25 μg

COVID-19 vaccination 

status as of 

September 2023
Previously received 

COVID-19 vaccine(s)

Recommendations 

for 2023–2024 

vaccine, by 

manufacturer

Unvaccinated

OR

Proposed recommended 2023–2024 COVID-19 vaccines for people who ARE moderately or severely immunocompromised, 

aged ≥12 years*

2 doses 

any 

Moderna

OR

1 dose 

any 

Moderna

1 dose 

any 

PfizerBioNTech

2 doses 

any 

PfizerBioNTech

1 or more doses of 

Novavax or Janssen, 

including in 

combination with any 

mRNA vaccine dose(s)

Vaccinated

2023–2024 

Moderna

3 doses

0.5 mL/50 μg

2023–2024 

PfizerBioNTech

3 doses

0.3 mL/30 μg

2023–2024 

Moderna

2 doses

0.5 mL/50 μg

2023–2024 

Moderna

1 dose

0.5 mL/50 μg

2023–2024 

Moderna

1 dose

0.5 mL/50 μg

2023–2024 

PfizerBioNTech

1 dose

0.3 mL/30 μg

2023–2024 

PfizerBioNTech

2 doses

0.3 mL/30 μg

2023–2024 

PfizerBioNTech

1 dose

0.3 mL/30 μg

3 or more 

doses any 

mRNA 

vaccine

*For information about administration intervals, people who transition from age 11 years to age 12 years during an mRNA vaccination series, and administration 

of additional dose(s), see Table 2 in Interim Clinical Considerations for Use of COVID-19 Vaccines. 

COVID-19 vaccination 

status as of 

September 2023
▪ Everyone aged 5 years and older are recommended get one 2023–2024 COVID-19 

vaccine to be up to date.

▪ Children aged 6 months–4 years and people who are moderately or severely 

immunocompromised need multiple doses, including at least one 2023–2024 COVID19 vaccine dose to be up to date. 

▪ People who are moderately to severely immunocompromised may get additional doses 

of the 2023–2024 COVID-19 vaccine.

Proposed 2023 – 2024 COVID-19 Vaccine Up to Date 

Definition
Simultaneous administration of 

COVID-19 and other vaccines
▪ In accordance with General Best Practice Guidelines for Immunization, routine 

administration of all age-appropriate doses of vaccines simultaneously (i.e., 

administering more than one vaccine on the same clinic day or “coadministration”) is 

recommended for children, adolescents, and adults if there are no contraindications at 

the time of the healthcare visit. 

– Providers may simultaneously administer COVID-19, influenza, and respiratory syncytial virus (RSV) vaccines to 

eligible patients; the Health Alert Network (HAN) published on September 5, 2023 may be consulted for 

additional information about simultaneous administration of these vaccines.

– Simultaneous administration of COVID-19 vaccine and nirsevimab (a long-acting monoclonal antibody for certain 

infants and young children for prevention of RSV) is recommended

– Coadministration of COVID-19 and RSV vaccine for older adults is acceptable

– There are additional considerations if administering an orthopoxvirus vaccine and COVID-19 vaccine 

Simultaneous administration of COVID-19 and other vaccines

Interim Clinical Considerations for Use of COVID-19 Vaccines | CDC

Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Disease Among Infants and Young Children: Recommendations of the Advisory Committee on Immunization 

Practices — United States, 2023 | MMWR (cdc.gov)

Healthcare Providers: RSV Vaccination for Adults 60 Years of Age and Over | CDC

Interim Clinical Considerations for Use of JYNNEOS and ACAM2000 Vaccines during the 2022 U.S. Mpox Outbreak | Mpox | Poxvirus | CDC